Kornimate/medical-research-clean huggingface dataset:
a study of different titration schedules of alks 5461 in adults with major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: this is a phase 3 study designed to evaluate the safety and tolerability of two titration schedules for alks 5461.


Eligibility criteria:
inclusion criteria: * body mass index of 18-40 kg/m2 * have a diagnosis of mdd * have a current major depressive episode (mde) lasting 8 weeks to 24 months * have been treated with an adequate dose of an approved antidepressant during the current mde for at least 8 weeks * have an inadequate response to current antidepressant treatment * agree to use an approved method of birth control for the duration of the study * additional criteria may apply exclusion criteria: * currently pregnant or breastfeeding * history of or current infection with hepatitis b virus, hepatitis c virus or human immunodeficiency virus (hiv) * have experienced hallucinations, delusions, or any psychotic symptoms in the current mde * have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days * have received electroconvulsive therapy treatment within the last 5 years * have attempted suicide within the past 2 years * have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone) * have had a significant blood loss or blood donation with 60 days of screening * additional criteria may apply

Keywords: depression major depressive disorder alkermes alks 5461 samidorphan buprenorphine
recording methods of muscle activity "onset".

Conditions: Low Back Pain

Summary: delayed anticipatory muscle activity response in deep low back and abdominal muscles has been observed in patients with low back pain, indicative of a pathological condition. muscle activity onset is traditionally recorded by intramuscular electromyography, but there is a need for a less cumbersome recording method in large clinical studies. the purpose of this experimental study is to explore whether high-frame rate m-mode ultrasound and tissue velocity imaging could measure anticipatory muscle responses ("onset") in the abdominal muscles reliably and comparably accurate to intramuscular emg.


Eligibility criteria:
inclusion criteria: * healthy * 30-65 yrs exclusion criteria: * recent low back pain * low back, neck or shoulder pain inflicting work absence or bed rest * cardiac, rheumatic or other serious illness * pregnancy

Keywords: low back pain neuromuscular control anticipatory motor control musculoskeletal physiologic processes muscle, skeletal ultrasonography electromyography
development of a health-related symptom index for participants with and either treated or monitored for anal high-grade squamous intraepithelial lesions

Conditions: High Grade Anal Canal Squamous Intraepithelial Neoplasia; Human Immunodeficiency Virus

Summary: this trial develops a health-related symptom index for participants with and either treated or monitored for anal high-grade squamous intraepithelial lesions. the health-related quality of life index may help to capture the symptoms and related experiences of living with or being treated for high-grade squamous intraepithelial lesions.

primary objectives: i. to develop a spanish-language version of the anal cancer/high-grade squamous intraepithelial lesions outcomes research (anchor) high-grade squamous intraepithelial lesions (hsil) health-related quality of life (hrqol) index (hqi) using state-of-the-art measure development methodology that captures the most important hrqol symptoms and concerns of those persons diagnosed with anal hsil and either treated or untreated for anal hsil. outline: participants take part in cognitive interviews in spanish over 45-60 minutes.

Eligibility criteria:
inclusion criteria: * human immunodeficiency virus (hiv)-1 infection. * biopsy-proven anal hsil within the prior nine months. * participant must have received anal hsil treatment in the last nine months. if the participant's treatment plan is observation? the participant must have been diagnosed with anal hsil in the last nine months. * life expectancy of greater than 5 years. * fluent in spanish with limited english proficiency, per self-report. exclusion criteria: * history of anal cancer. * inability to understand a written consent form.
the individual response of healthy individuals to mental fatigue

Conditions: Mental Fatigue

Summary: the objective of the present study is to confirm and map out the presence of interindividual differences in the effect of mental fatigue on both physical and cognitive performance, and to see if these differences are related to individual factors of the participants.

every participant will visit the lab a total of three times within a period of two weeks. in the first visit, they will undergo both a detailed screening as well as perform all intervention/control trial measures to familiarize themselves with the utilised equipment. this detailed screening entails, among other things, a maximal incremental exercise test, a cognitive test battery and multiple subjective questionnaires. the experimental and control trial are almost identical, with the only difference being the task performed in the middel of the trial. at the beginning of the trial the eeg will be fitted to the head of the participant and baseline measures will be taken. afterwards, participants will perform a go nogo task to assess baseline cognitive performance. then the intervention (i.e. stroop task) or control (i.e. documentary) task will be performed. the goal of the stroop task is to elicit mental fatigue, while the documentary provides a meaningful comparison. afterwards, cognitive performance will again be assessed using the go no go task, followed by a physical performance task in the form of a time trial. the different internal factors assessed during the screening stage will be correlated to the difference in cognitive and physical performance between the intervention and control trial.

Eligibility criteria:
inclusion criteria: * healthy (no neurological, cardiovascular or musculoskeletal disorders of any kind) * no prior knowledge of the concept of mental fatigue * no medication * non-smoker exclusion criteria: * injuries of any kind in the past 6 months * suffering from a chronic health condition (could be neurological, cardiovascular, internal and musculoskeletal) * participating in any concomitant care or research trials * history of suffering from any mental/psychiatric disorders * suffering from a higher risk of burn out, indicated by a total score of ≥ 2.59 on the burn out assessment tool (bat) * suffering from high general fatigue, indicated by a score of \>59 on the multidimensional fatigue inventory (mfi) * suffering from depression, indicated by a score of \>16 on the beck depression inventory-ii (bdi-ii) * use of medication * use of caffeine and heavy efforts 24 hours prior each trial * suffering from colour vision deficiencies * not eating a standardized meal, the morning of each trial
study of ravulizumab in pediatric participants with hsct-tma

Conditions: Thrombotic Microangiopathy

Summary: this study will evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of ravulizumab administered by intravenous infusion to pediatric participants, from 1 month to \< 18 years of age, with hsct-tma. the treatment period is 26 weeks, followed by a 26-week off-treatment follow-up period.


Eligibility criteria:
inclusion criteria: 1. ≥ 28 days of age up to \< 18 years of age at the time of signing the informed consent. 2. received hsct within the past 12 months. 3. diagnosis of tma that persists for at least 72 hours after initial management of any triggering agent/condition. 4. a tma diagnosis based on meeting the laboratory-based criteria during the screening period and/or ≤14 days prior to the screening period. 5. body weight ≥ 5 kilograms at screening or ≤7 days prior to the start of the screening period (date of consent). 6. female participants of childbearing potential and male participants with female partners of childbearing potential must use highly effective contraception. 7. participants must be vaccinated against meningococcal infections if clinically feasible. participants who cannot receive meningococcal vaccine should receive antibiotic prophylaxis. participants \<18 years of age must be re-vaccinated against haemophilus influenzae type b (hib) and streptococcus pneumoniae if clinically feasible. 8. participants or their legally authorized representative must be capable of giving signed informed consent or assent. exclusion criteria: 1. thrombotic thrombocytopenic purpura (ttp) evidenced by adamts13 deficiency. 2. known shiga toxin-related hemolytic uremic syndrome as demonstrated by positive test. 3. positive direct coombs test indicative of a clinically significant immune-mediated hemolysis not due to tma. 4. clinical diagnosis of disseminated intravascular coagulation (dic). 5. known bone marrow/graft failure for the current hsct. 6. diagnosis of veno-occlusive disease (vod) which is unresolved at the time of screening. 7. human immunodeficiency virus (hiv) infection. 8. unresolved meningococcal disease. 9. presence of sepsis requiring vasopressor support. 10. pregnancy or breastfeeding. 11. hypersensitivity to murine proteins or to 1 of the excipients of ravulizumab. 12. any ongoing or history of medical or psychological conditions unrelated to hsct-tma that could increase the risk to the participant or confound the outcome of the study. 13. respiratory failure requiring mechanical ventilation. 14. previously or currently treated with a complement inhibitor. 15. participation in an interventional treatment study of any therapy for tma.

Keywords: thrombotic microangiopathy (tma) ultomiris ravulizumab hematopoietic stem cell transplant
salivary bacterial associations to short term discontinuation of self-performed oral hygiene

Conditions: Mouth Diseases

Summary: the purpose of the present investigation is to record and compare bacterial compositions in supragingival plaque samples and saliva samples in subjects discontinuing regular oral hygiene for 10 days. the hypothesis is that the composition of the salivary microbiota might reflect local bacterial alterations in relation to discontinuation of oral hygiene.

35 orally healthy individuals will be enrolled in this study, in which they will discontinue regular oral hygiene procedures for a period of 10 days. clinical registrations and collection of microbiological samples (supragingival and saliva) will be performed at baseline and 4, 7 and 10 days after discontinuation of regular oral hygiene, and will be repeated 14 days after regular oral hygiene has been resumed.

Eligibility criteria:
inclusion criteria: * oral and systemically healthy individuals exclusion criteria: * periodontitis * dental caries * systemic diseases or medications with known associations to oral health * antibiotics within the latest 6 month

Keywords: biofilm saliva bacteria oral hygiene
efficacy and safety of apremilast in psoriasis

Conditions: Psoriasis

Summary: psoriasis is a long standing inflammatory, autoinflammatory disease linked with many comorbidities. patients with moderate to severe plaque psoriasis can be managed with topical as well as systemic medications. fda approved apremilast as first drug to be taken orally in cases of psoriasis in mid 1990's. currently, according to researchers best knowledge no study has been done on use of apremilast in pakistan. it has recently become available here. keeping in view all the benefits of this drug, a study has been planned to check its effectiveness and safety 30mg twice a day, in patients with moderate to severe chronic plaque psoriasis based on psoriasis area and severity index and body surface area assessments in our population.


Eligibility criteria:
inclusion criteria: * diagnosed patients of chronic plaque psoriasis * patients applicant for oral or parenteral treatments and for light therapy * patients not responding to topical treatments exclusion criteria: * patients who show hypersensitive reactions to apremilast to any of its inactive component * pregnancy * lactating mothers
an extension study of the safety and anti-leukemic effects of imatinib mesylate in participants with philadelphia chromosome-positive chronic myeloid leukemia in blast crisis

Conditions: Philadelphia Chromosome Positive CML

Summary: this extension ii study allowed for further follow-up of the disease under treatment with imatinib mesylate and allow the participants to continue to receive imatinib mesylate.


Eligibility criteria:
inclusion criteria: 1. participants with philadelphia chromosome positive chronic myelogenous leukemia (cml) in myeloid blast crisis (including both newly diagnosed and the participants who received prior therapy for accelerated or blastic phases), defined as either: 1. ≥ 30% blast in peripheral blood and /or bone marrow 2. by flow cytometry criteria 2. to be categorized as "newly diagnosed", participants with cml in blast crisis were not to have received specific therapy for cml accelerated or blast phases, with the exception of interferon-alpha or hydroxyurea. 3. serum glutamic-oxaloacetic transaminase (sgot) and serum glutamic-pyruvic transaminase (sgpt) not more than 3 times the upper limit of the normal range (uln) (or not more than 5 times the uln if clinically suspected leukemic involvement of the liver), serum creatinine concentration not more than 2 times the uln, and total serum bilirubin level not more than 3 times the uln at the laboratory where the analyses were performed. 4. a negative pregnancy test in participants of childbearing potential. exclusion criteria: 1. participants with an eastern cooperative oncology group (ecog) performance status score ≥ 3. 2. participants previously treated for blast crisis were not to have received any of the following with respect to day 1 of the study: busulfan within six weeks, interferon-alpha within 48-hours, hydroxyurea within 24-hours, homoharringtonine within 14 days, low-dose, moderate dose or high dose cytosine arabinoside within 7, 14 and 28 days respectively, anthracyclines, mitoxantrone, or etoposide within 21 days. 3. participants receiving any hematopoietic stem cell transplantation within six weeks of day 1. 4. participants receiving any other investigational agents within 28 days of day 1. 5. participants with grade 3/4 cardiac disease or any other serious concurrent medical conditions. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: chronic myelogenous leukemia cml philadelphia chromosome blast crisis imatinib mesylate
the use of tulsi extract for the management of oral mucositis in head & neck cancer patients undergoing radiotherapy

Conditions: Stomatitis

Summary: after signing the informed consent, the participant will be allocated to either intervention or control group, then each participant will use either 0.15% benzydamine (comparator) or 4% tulsi (intervention) four times a day and also once half an hour before each radiotherapy session.

the primary outcome is the severity of oral mucositis will assess by oral mucositis assessment scale (omas) and secondary outcomes are pain will assess numerical rating scale (nrs), oral assessment guide (oag), and patient-reported oral mucositis( proms scale) all outcomes will be recorded at baseline, and 8, 15 days

Eligibility criteria:
inclusion criteria: * patients having clinical signs of radiotherapy-induced om (who oral mucositis grading scale: grade ii, iii, and iv) * patient should be able to read and/or understand and sign the consent form. exclusion criteria: 1. patients with hiv infections or hyperthyroidism. 2. karnofsky performance status (kps) less than 60% 3. patients having an allergy to tulsi or benzydamine hcl 4. patients who are pregnant and/or nursing.

Keywords: oral mucositis tulsi extract benzydamine hydrochloride radiotherapy
study of ni-071 in comparison with remicade in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to compare the safety of ni-071 with remicade® (infliximab) in patients with rheumatoid arthritis inadequately treated with methotrexate.


Eligibility criteria:
inclusion criteria: 1. diagnosis of rheumatoid arthritis (ra) as defined by the 1987 revised american college of rheumatology (acr) criteria with acr functional classification class i-iii and disease duration of no less than 3 months 2. patients must receive a minimum of 3 months treatment with methotrexate (mtx) (≥ 6 mg/week) prior to the screening visit. patients must be on a stable dose of mtx (6 mg\~16 mg mg/week) for a minimum of 4 weeks prior to the screening visit exclusion criteria: 1. history of following diseases * other connective tissue disorders with joint symptom which may interfere the efficacy assessment * chlonic or recurrent infectious disease（bronchial ectasia, sinus inflammation etc.） * severe infectious disease（hepatitis, pneumonia、sepsis） * history of demyelinating disease or multiple sclerosis * congestive heart failure * lymphoproliferative disorder or myelodysplastic syndrome * history of malignancy * interstitial lung disease 2. patients with active or latent tuberculosis or history of tuberculosis
citrate pharmacokinetics and regional citrate anticoagulation in crrt

Conditions: Acute Kidney Failure With or Without:; MODS; Sepsis; Hepatic Insufficiency

Summary: 1. to compare the differences of citrate pharmacokinetics in healthy individuals and critically ill patients as well as the influential factors. 2. to validate a pharmacokinetic model which has been established in a formal paper. 3. to create a safe and effective rca-crrt protocol.


Eligibility criteria:
inclusion criteria: * healthy individuals, none-pregnant * diagnosed with acute renal failure according to rifle criteria * arf with hepatic insufficiency * arf with mods or sepsis * within informed consent exclusion criteria: * used drugs with citrate within one week * infused with blood,plasma or platelet or undergone plasma exchange therapy within 48 hours * serious alkalosis with ph\>7.55 * serious lactic acidosis * not in resuscitation state

Keywords: citrate anticoagulation pharmacokinetic critically ill acute kidney failure
study of concurrent chemotherapy and radiotherapy for stage ii nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the primary objective of this study is to determine the overall survival in patients with stage ii (t1-2n1m0) npc treated with concurrent chemotherapy and radiotherapy. secondary objectives of the study are to evaluate the disease free survival, and distant metastases free survival of patients with stage ii npc treated with this regimen

radiotherapy alone is the standard treatment for early stage npc. in retrospective study of early stage npc patients treated with radiotherapy alone. patients who had stage ii disease had a worse outcome compared with patients with stage i disease. chemotherapy, delivered concurrently with radiation therapy, has been adopted as standard treatment for locally advanced npc. however, concurrent chemoradiation for stage ii npc patients has never been prospectively studied. in the present trial, we hope to assess the value of concurrent chemotherapy and radiotherapy in patients with stage ii (t1-2n1) npc.

Eligibility criteria:
inclusion criteria: * histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx. * stage ii disease (t1-2; n1; m0) * kps \>70 * age between 18-70 * patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (agc) of \> 2000 cells/mm3, platelet count of \> 100,000 cells/mm3 (pre treatment without intervention). bilirubin \ 50ml/min. * no prior radiation treatment to the head and neck or any prior chemotherapy * patients with no prior malignancy (not include basal cell carcinoma of skin) exclusion criteria: * evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations. * prior radiotherapy to the head and neck region for any reason. * initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease. * patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin. * pregnant women.

Keywords: phase 2 clinical trial npc radiation therapy chemotherapy
effect and tolerance of a probiotic-based medical device administered to patients with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: this is an observational, open, longitudinal, multicentre study conducted in france. the study plans to enrol 119 patients with irritable bowel syndrome who will be included by about 50 general practitioners or gastroenterologists consulting in private offices. the treatment, lactiplus® is a medical device, in the form of capsules containing l. gasseri la806. the main objective of the study is to assess the effect of a 4-week treatment with the medical device on abdominal pain.

the study is designed as an observational post-market follow-up study, to confirm the performance of the medical device in real life conditions and document its safety profile. the eligible population corresponds to the population that could benefit from the treatment, according to the md's instructions for use. non-inclusion criteria prevent from including patients with other pathologies associated with gastro-intestinal troubles, who may beneficiate from more adequate treatments.

Eligibility criteria:
inclusion criteria: * adult (age ≥ 18 years) * suffering from ibs (rome iv criteria), whatever the predominant stool pattern, i.e recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria: related to defecation; associated with a change in frequency of stool; associated with a change in form (appearance) of stool; with symptom onset at least 6 months before diagnosis; * having access to electronic tools (computer, tablet...) and an internet connection, allowing him to complete the online self-questionnaire. exclusion criteria: * presence of clinical signs of alarm such as rectorrhagia, fever or recent unexpected weight loss or patient with suspicion or evidence of diseases that exclude ibs diagnosis: including but not limited to inflammatory gastrointestinal disease (e.g. crohn's disease, ulcerative colitis), colorectal cancer, celiac disease, hyperthyroidism, intestinal infection, lactose intolerance, other malabsorption syndromes (e.g.: fructose), bile acid malabsorption; * history of abdominal surgery except appendectomy; * allergy or hypersensitivity to one of the ingredients of the medical device; * inability to fill self-questionnaires or to understand the information notice (cognitive or linguistic issues); * participation to another clinical study or in the exclusion phase of a previous clinical study; * refusal to participate.